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ACTIVE NOT RECRUITING
NCT05429268
PHASE3

Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

Official title: A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2022-12-23

Completion Date

2027-04-01

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DRUG

Tafasitamab

Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.

DRUG

Lenalidomide

Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.

Locations (61)

Medical University Plovdiv

Plovdiv, Bulgaria

Acibadem Cityclinica Mhat Tokuda

Sofia, Bulgaria

Umhat Alexandrovska Sofia

Sofia, Bulgaria

Umhat Sv. Ivan Rilski Ead

Sofia, Bulgaria

Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood

Sofia, Bulgaria

Clinical Hospital Dubrava

Zagreb, Croatia

Clinical Hospital Merkur

Zagreb, Croatia

University Hospital Centre Zagreb

Zagreb, Croatia

Fakultni Nemocnice Olomouc

Olomouc, Czechia

Vseobecna Fakultni Nemocnice

Prague, Czechia

Aarhus University Hospital

Aarhus, Denmark

Odense University Hospital

Odense, Denmark

Helsinki University Central Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Semmelweis Egyetem

Budapest, Hungary

National Institute of Oncology

Budapest, Hungary

University of Debrecen

Debrecen, Hungary

Markhot Ferenc Korhaz

Eger, Hungary

Somogy Medyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Szeged, Hungary

Bon Secours Hospital

Cork, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

University Hospital Galway

Galway, Ireland

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Mc

Jerusalem, Israel

Hadassah University Hospital

Jerusalem, Israel

Meir Medical Center

Kefar Sava, Israel

Akershus University Hospital

Lorenskog, Norway

Universitetssykehuset I Trondheim - St. Olavs Hospital

Trondheim, Norway

Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela

Bydgoszcz, Poland

Medical University of Gdansk

Gdansk, Poland

Szpital Morski Im. Pck Sp. Z O.O

Gdynia, Poland

University Public Hospital Nr 1

Lublin, Poland

Oddzia Kliniczny Hematologii

Olsztyn, Poland

Pratia Poznan

Skórzewo, Poland

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

Wroclaw, Poland

Coltea Clinical Hospital

Bucharest, Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, Romania

Institutul Regional de Oncologie Iasi

Iași, Romania

Spitalul Clinic Judetean de Urgenta Targu Mures

Târgu Mureş, Romania

Clinic For Hematology, University Clinical Center Serbia

Belgrade, Serbia

Institute For Pulmonary Diseases of Vojvodina

Kamenitz, Serbia

Clinical Center Kragujevac

Kragujevac, Serbia

Clinic of Hematology Clinical Center of Vojvodina

Novi Sad, Serbia

Hacettepe University Cancer Institute Clinical Oncology Department

Ankara, Turkey (Türkiye)

Gazi University Hospital Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Ozel Liv Hospital Onkoloji Klinigi

Ankara, Turkey (Türkiye)

Tekrda-Nk Tp Fakltesi

Center, Turkey (Türkiye)

Vkf American Hospital

Istanbul, Turkey (Türkiye)

Marmara Universitesi Pendik Egitim

Istanbul, Turkey (Türkiye)

Ege University Hospital

Izmir, Turkey (Türkiye)

Ercyes University Medical School

Kayseri, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi

Yenimahalle, Turkey (Türkiye)

Antrim Area Hospital Northern Health Social Care Trust

Antrim, United Kingdom

Belfast Health and Social Care Trust, of Trust Headquarters

Belfast, United Kingdom